FDA: Medtronic Waited Two Years to Recall Pumps

Medtronic Inc. apparently waited two years to recall Synchromed pumps that were implanted in patients without being filled with the required propellant, according to a recent warning letter by the U.S. Food and Drug Administration.

Although Medtronic identified the problem in May 2006, it did not recall the pumps until May 2008, according to the document, which came after inspectors visited a Puerto Rico plant of the Minneapolos, Minn.-based medial device giant at November and December 2008.

View the complete warning letter at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm168451.htm.